Bonanno, Silvia http://orcid.org/0000-0002-8823-6821
Giossi, Riccardo http://orcid.org/0000-0002-7352-9445
Zanin, Riccardo
Porcelli, Valentina
Iannacone, Claudio
Baranello, Giovanni
Ingenito, Gary
Iyadurai, Stanley
Stevic, Zorica
Peric, Stojan
Maggi, Lorenzo http://orcid.org/0000-0002-0932-5173
Clinical trials referenced in this document:
Documents that mention this clinical trial
Amifampridine safety and efficacy in spinal muscular atrophy ambulatory patients: a randomized, placebo-controlled, crossover phase 2 trial
https://doi.org/10.1007/s00415-022-11231-7
Documents that mention this clinical trial
Funding for this research was provided by:
Catalyst Pharmaceuticals, Inc
Article History
Received: 13 March 2022
Revised: 13 June 2022
Accepted: 14 June 2022
First Online: 28 June 2022
Declarations
:
: S. Bonanno received honoraria for advisory board activities and compensation for travel and congress participation from Sanofi Genzyme, Biogen and Roche; R. Giossi received support for congress participation from Mylan; R. Zanin received funds for travel and congress participation from Biogen; V. Porcelli has nothing to disclose; C. Iannacone has received honoraria for statistical consultancy from Roche, Bayer-Schering, ReiThera, Abiogen, and MolMed; G. Baranello received speaker and consulting fees from Biogen, Novartis Gene Therapies, Inc. (AveXis), and Roche and has worked as principal investigator of SMA studies sponsored by Novartis Gene Therapies, Inc., and Roche; G. Ingenito has corporate appointment with Catalyst Pharmaceuticals; S. Iyadurai has corporate appointment with Catalyst Pharmaceuticals; Z. Stevic reports following conflicts of interest, all outside this work: receiving lecture honoraria from Pfizer and Roche; S. Peric reports following conflicts of interest, all outside this work: receiving lecture honoraria from Pfizer, Teva Actavis, Berlin Chemie Menarini, Mylan, Worwag, Adoc, and Salveo, research grants from Kedrion and Octapharma, consultant fees from argenx and Mylan, and travel grants from Octapharma, Kedrion, Teva Actavis, Sanofi Genzyme, Pfizer, Roche, Adoc, and Berlin Chemie Menarini, and reports no other conflicts of interest outside or related to this work; L. Maggi has received honoraria for speaking, advisory boards and compensation for congress participations from Sanofi Genzyme, Roche and Biogen, outside the submitted work.
: The trial was conducted in accordance with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Guidance Good Clinical Practice, the 1964 Declaration of Helsinki and its later amendments, local applicable law and regulatory requirements, was approved by institutional review boards and ethical committees of each participating center, and was registered in ClinicalTrials.gov (NCT03781479) and EUDRACT (2017-004600-22). All patients provided a written informed consent before any study procedure was performed, i.e., before the screening visit.
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